Kornimate/medical-research-clean huggingface dataset:
bariatric surgery on short term weight loss- related changes in gait

Conditions: Obesity, Morbid

Summary: this is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (qol) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.

this is a prospective, exploratory, short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (qol) in morbidly obese patients. all patients who enroll have already agreed to undergo the bariatric procedure with their respective surgeon; the study team will simply follow specific outcome measures in addition to their normal clinical care at two time points after the surgery (week 4 and month 3).

Eligibility criteria:
inclusion criteria: * no urgent need for bariatric procedure * 21-65 years of age * body mass index (bmi) 35 kg/m2 or greater, defined as morbid obesity * waist circumference of \< 66 inches * able to walk independently exclusion criteria: * \ 65 years of age * pregnancy; psychiatric conditions; binge eating patterns; prader-willi syndrome; drug dependency; dementia or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol * uncontrolled diabetes (not using meds) * waist circumference of \> 66 inches * orthopedic conditions that prevent ambulation (severe painful osteoarthritis of the hip or knee) * patient is wheelchair bound

Keywords: body composition gait quality of life patients undergoing bariatric surgery.
breast lesion in ct chest

Conditions: Breast Cancer Female

Summary: the aims of this study are to evaluate the ct features of incidental breast lesions on chest ct and subsequently suggest useful criteria for referral to a specialized breast unit.

enhanced chest ct examination reports containing the key word 'breast' well be reviewed retrospectively. patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included. finally, 100 patients well be enrolled. two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement. the correlations between the ct features and pathologies well be evaluated and the diagnostic accuracy of ct features in various combinations well be assessed.

Eligibility criteria:
inclusion criteria: * inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest ct and were referred to a specialized breast unit for assessment and then underwent pathological confirmation. exclusion criteria: * -patients with known breast dis ease. * previous history of breast cancer or breast surgery. * patients who had undergone only non-enhanced ct examination.
effects and safety of steam eye mask with acupoints stimulation

Conditions: Dry Eye Symptom; Eye Fatigue

Summary: to evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree c for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of quality of life (qol) in vdt users.

a prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in vdt users. the effects and safety of the single therapy by the moist heat of approximately 40 degree c for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.

Eligibility criteria:
inclusion criteria: 1. males or females aged from 20 to 69 years old (both inclusive). 2. participants who use vdts, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day. 3. participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire. 4. participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire. 5. participants are able and willing to comply with all protocol requirements and procedures. 6. participants who must be capable of providing informed consent document, with one's signature. exclusion criteria: 1. participants with eye diseases that could affect the ocular surface (e.g. ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases). 2. participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease. 3. participants with the excessive meibomian lipid secretion (seborrheic mgd). 4. participants with trauma, swelling and eczema at the skin around eyes. 5. participants with allergic reaction for heating, abnormality of the heat or depression of the heat. 6. participants who are deemed inappropriate to participate in this study by physicians.

Keywords: steam eye mask acupoints stimulation dry eye symptom eye fatigue visual display terminal moist heat massage
a study to evaluate the safety and efficacy of azx100 drug product following excision of keloid scars

Conditions: Scar Prevention; Scar Reduction

Summary: the purpose of this study was to determine the safety of azx100 drug product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.


Eligibility criteria:
inclusion criteria: * keloid scar between 1 and 3 cm long, less than 1 cm at its widest point * willing to undergo keloid scar removal surgery * healthy adult male or non-pregnant female * non-diabetic * body mass index in the range of 18-35 * no clinically significant abnormal values on a full blood safety screen * non-smoker and non-nicotine user for the previous six months exclusion criteria: * history or clinical evidence of acute or chronic disease * history of malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area * history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction * allergy to local anesthesia, including lidocaine and epinephrine * ongoing dermatologic disorders, except for folliculitis and acne * on therapy with steroids * on therapy with a drug that would affect collagen synthesis * positive urine test for nicotine or drugs of abuse * positive blood test for hiv 1 or 2, hepatitis b or hepatitis c * positive blood test for anti-azx100 antibodies * participation in another study within 60 days prior to enrollment * donate blood within 7 days before dosing with study drug * donate plasma within 3 days before dosing with study drug * have a tattoo within 3 cm of the keloid scar that will be removed * apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug * use a tanning bed or tanning light within 3 months before enrollment * intend to use any scar improving product during the study (one year) * history of drug addiction or excessive use of alcohol * previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed

Keywords: azx100 patient and observer scar assessment scale posas visual analog scale vas keloid scarring scar reduction scar prevention
influence of esomeprazole on antiplatelet action of clopidogrel associated with aspirin

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Summary: the investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. at least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. clopidogrel effect was tested by measuring residual platelet reactivity (rpr) to adp by verifynow p2y12 assay (accumetrics inc, san diego, calif). at baseline, whole blood will be obtained for rpr at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. double blinding will be performed by encapsulation of study drugs. rpr will be measured again at the 28th day. the investigators will compare the % inhibition and the p2y12 reaction units (pru) at the 28-day treatment period in the 2 groups.


Eligibility criteria:
inclusion criteria: * patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (pci) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited. exclusion criteria: * known active peptic ulcer disease or gastrointestinal within 8 wk * known iron deficiency anemia with hb \< 10 gm/dl * mechanical ventilation * active cancer, liver cirrhosis, end-stage renal failure * life expectancy \< 1 yr * known allergic to aspirin, clopidogrel, famotidine or esomeprazole * pregnancy, lactation, child-bearing potential in the absence of contraception, * co-prescription of nsaid, corticosteroid, or warfarin * non-oral feeding or impaired gi absorption e.g. vomiting * patient on proton pump inhibitor within 4 weeks

Keywords: acute coronary syndrome acute myocardial infarction percutaneous coronary intervention aspirin clopidogrel esomeprazole famotidine platelet function
evaluation of milk polar lipids in dyslipidemic adults with abdominal obesity

Conditions: Dyslipidemias; Obesity

Summary: the major objective of this project is to examine whether daily consumption of milk polar lipids (mpls) influences cardiometabolic risk factors.

the investigators will conduct a randomized, double-blind, controlled, parallel, intervention study in dyslipidemic adults with abdominal obesity (n = 130). participants will consume either a control dairy beverage (n = 65) or an mpl-rich dairy beverage (n = 65) for 8 weeks. the investigators plan to evaluate the following 4 specific objectives: 1. determine the effects of mpls on serum lipid concentrations and other cardiometabolic risk factors. 2. evaluate the effects of mpls on systemic biomarkers of low-grade inflammation. 3. examine the effects of mpls on lipoprotein metabolism and lipoprotein particle characteristics. 4. evaluate the effects of mpls on gut microbiota, gut permeability markers, and fecal lipids.

Eligibility criteria:
inclusion criteria: * ldl-c ≥ 130 mg/dl * waist circumference ≥ 88 cm for women, ≥ 102 cm for men * aged 18 to 70 years exclusion criteria: * renal disease * liver disease * diabetes * heart disease * stroke * cancer * eating disorders * thyroid disease * gut-associated pathologies * autoimmune diseases * chronic inflammatory diseases * scleroderma * gallbladder disease * blood clotting disorders * intravenous drug use * fasting plasma/serum triglycerides \>500 mg/dl * fasting plasma/serum glucose \>126 mg/d * weight changes \>10% over last 4 weeks * oral antibiotics use up to 1 month prior to and during study * allergy or intolerance to milk products * taking lipid-lowering medications (e.g., statins, fibrates) * taking anti-inflammatory medications (e.g., corticosteroids) * taking medications which primarily affect blood clotting (e.g., warfarin).
a study in pregnant women with chronic inflammatory diseases treated with cimzia (certolizumab pegol)

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Crohn's Disease; Axial Spondyloarthritis; Plaque Psoriasis

Summary: the purpose of the study is to assess systemic certolizumab pegol (czp) exposure, the formation of anti-czp antibodies and safety of czp across the course of pregnancy in study participants with chronic inflammatory diseases.


Eligibility criteria:
inclusion criteria: * participant is pregnant and ≤10 weeks gestation at the time of enrollment * participant must have been on stable, maintenance dose certolizumab pegol (czp) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician * participant expects to continue czp therapy throughout pregnancy and for at least 12 weeks postpartum * participant has a negative interferon gamma release assay (igra) or tuberculin skin test (tst) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. participants with documented bacillus calmette-guérin (bcg) vaccine and at low risk for tuberculosis (tb) may enroll without having a tb test performed exclusion criteria: * participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study * participant is not permitted to enroll into the study if she meets any of the following tb exclusion criteria: 1. known active tb disease 2. history of active tb involving any organ system 3. latent tb infection 4. high risk of acquiring tb infection 5. current nontuberculous mycobacterial (ntm) infection or history of ntm infection (unless proven to be fully recovered) * study participant is taking a prohibited medication or has taken a prohibited medication * live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study * study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator * study participant had a positive or indeterminate interferon gamma release assay (igra) or tuberculin skin test (tst) at screening. in case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant

Keywords: cimzia certolizumab pegol pregnant women crohn's disease (cd) rheumatoid arthritis (ra) psoriatic arthritis (psa) plaque psoriasis (pso) axial spondyloarthritis (axspa) pharmacokinetics czp
observational study of the heart repair technologies mitral bridge in treating mitral valve regurgitation

Conditions: Mitral Regurgitation

Summary: prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular mitral bridge™ to reduce or eliminate mitral regurgitation.

the primary objective of this study is to evaluate the safety and performance of the mitral bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the american society of echocardiography (ase). the device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane. the protocol was designed as a first in man (fim) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.

Eligibility criteria:
inclusion criteria: * patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass * mitral regurgitation must meet the following criteria: * the primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve. * if a secondary jet is present, the jet must be considered clinically insignificant. * women of child-bearing potential have a negative pregnancy test exclusion criteria: * evidence of severe mitral annular and leaflet calcification. * patient is hemodynamically unstable. * patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets. * patient requires emergency surgery. * patient has echocardiographic evidence of endocarditis or rheumatic heart disease. * transesophageal echocardiogram (tee) is contraindicated or cannot be performed intraoperatively for any reason. * patient has known chronic, dialysis-dependent renal failure. * history of stroke, transient ischemic attack (tia) or reversible ischemic neurological disease within the last three (3) months. * history of gastrointestinal bleeding within the last three (3) months. * history of hypersensitivity or allergy to aspirin * history or hypersensitivity to clopidogrel (plavix) or its congeners. * active or treated malignancies in the last twelve (12) months. * patient is participating in another clinical study for which follow-up is currently ongoing. * women of child-bearing age who have not had a negative pregnancy test. * patient with non-cardiac co-morbidities and life expectancy \< 1 year. * patient has a condition that, in the opinion of the investigator, precludes participation, including willingness to comply with all follow-up procedures.

Keywords: mitral insufficiency mitral valve incompetence
autostea for adults with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the goal of this study is to assess how effective the autostea device is in treating functional dyspepsia (upper abdominal discomfort) in adults. it will also assess the safety and usability of the device. the main questions it aims to answer are: * does the autostea device ease dyspepsia symptoms? * is the autostea device safe and feasible for patients to use at their home? participants will: * use the device for half an hour every day for two weeks * have a phone check-in halfway through the trial * answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.


Eligibility criteria:
inclusion criteria: * 18 and older * must meet rome iv criteria for functional dyspepsia exclusion criteria: * patients with dyspepsia symptoms that have been fully resolved by antisecretory, antidepressant, or prokinetic therapy * history of active nsaid use, unhealed esophagitis, unhealed ulcer disease, or other gi diseases that can explain their dyspepsia symptoms. * history of upper gi surgeries and upper gi cancers, uncontrolled diabetes (type 1 and 2), severe psychiatric conditions, uncontrolled medical disorders, total knee replacement surgery, or above-the-knee amputation. * patients with h. pylori infection without confirmed eradication will also be excluded.
metabolic effects of adjunctive lumateperone treatment in clozapine-treated patients with schizophrenia

Conditions: Schizophrenia; Schizo Affective Disorder

Summary: the main question this study is trying to answer is whether lumateperone, an fda-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. participants will be randomly assigned to either take lumateperone (caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. during their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).

this is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.

Eligibility criteria:
inclusion criteria: * meets the dsm-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the mini international neuropsychiatric interview (mini 7.0) * on clozapine treatment for at least 6 months * stable dose of antipsychotic treatment for at least 1 month * well established compliance with outpatient medications * subjects of child-bearing potential are required to practice appropriate birth control methods during the study. exclusion criteria: * psychiatrically unstable per clinical judgement by the principal investigator * patients not on stable dose of antipsychotic medications * currently meets dsm-5 criteria for any substance use disorder other than caffeine and nicotine * significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases * history of a seizure disorder * pregnancy or breastfeeding * on lumateperone treatment in the past 3 months * on a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)

Keywords: clozapine
anidulafungin pharmacokinetics in intensive care unit patients

Conditions: Invasive Candidiasis; Candidemia

Summary: the purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.

not a lot is known about the pharmacokinetic profile of anidulafungin in ic-patients. ic-patients are at high(er) risk for getting a systemic mould/yeast infection. anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. due to this, anidulafungin is used more often on ic-wards. it is part of the national (netherlands) ic sepsis protocol. the factors that influence the pharmacokinetics of anidulafungin in ic-patients has not been studied yet. because these factors are unknown for this population, it is necessary for this research to be done. any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen. 20 patients will be included from 2 different university hospital (10 each). samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor auc calculations.

Eligibility criteria:
inclusion criteria: * patient is admitted to the intensive care unit * patient has a central (venous) infusion line * patient is at least 18 years old * patient receives treatment with anidulafungin * that is initiated on the icu or * that is continued on the icu and the patient has had no more than 2 days of treatment with anidulafungin exclusion criteria: * documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation * patient receives treatment with anidulafungin that is continued on the icu and the patient has had 3 or more days of treatment with anidulafungin * a woman that is pregnant, wanting to become pregnant or nursing an infant * \< 48 hours (expected) treatment with anidulafungin on the icu ward * has previously participated in this trial.

Keywords: pharmacokinetics intensive care candidemia invasive candidiasis anidulafungin